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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
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Anaplastic large cell lymphoma (ALCL) is a rare Non-Hodgkin Lymphoma,which when occurring throughout the body (systemic) can be divided into 2 groups,depending on whether the lymphoma cells produce an abnormal form of protein called anaplastic lymphoma kinase (ALK). Both groups are aggressive (fast-growing) lymphomas,but the disease course is considered different in ALK-positive (ALK+) ALCL to ALK-negative ALCL.
For a significant proportion of patients,the disease either comes back after treatment (relapse) or does not respond to treatment (refractory). NIVO-ALCL is specifically designed for relapsed/refractory ALK+ ALCL patients. Notably,despite improvements in treatment for these patients,there remains no accepted ‘gold standard’. Furthermore most current treatments involve stem cell transplant using the patient’s own stem cells or those from a donor,and transplants are associated with some serious and long-term side-effects and can be fatal.
In NIVO-ALCL,an immunotherapy drug (nivolumab) will be used to treat the relapsed/refractory ALK+ ALCL,and it's effectiveness will be assessed according to set criteria. Nivolumab works with cells in the immune system (called T cells) that recognise and attack threats to the body,such as cancer cells.
NIVO-ALCL will recruit 2 cohorts of patients:
Cohort 1: Patients with active progressive disease after prior treatment will be treated with nivolumab alone for 24 months. Response will be assessed in terms of acceptable overall objective response within the first 24 weeks of treatment.
Cohort 2: Patients with complete remission after prior relapse therapy being considered for stem cell transplant as consolidation. In NIVO-ALCL,they will instead be treated with nivolumab alone for 24 months. Response will be assessed by progression free survival rate after trial entry and avoidance of the need for transplant.
Up to 43 patients will be included in the trial across the two cohorts internationally.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
E-1. Patients with prior allogeneic HSCT less than 3 months before study inclusion E-2. Patients with prior allogeneic HSCT and any active graft versus host disease (GVHD) and/or any prior grade 3 or 4 GVHD according to International Bone Marrow Transplant Registry (ITBMR) E-3. Previous organ transplantation E-4. Significant hemophagocytosis in bone marrow,spleen,lymph nodes,or liver must be discussed with the Coordinating Sponsor before inclusion E-5. Presence of any ≥ CTCAE grade 2 treatment-related toxicities with the exception of alopecia,fatigue and peripheral neuropathy. E-6. History or evidence of severe uncontrolled illness that contra-indicates use of an investigational drug,or places the patient at unacceptable risk from treatment complications E-7. History or evidence of severe acute or chronic infection unless fully healed at least four weeks prior to screening E-8. Known human immunodeficiency virus (HIV) infection E-9. Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. E-10. History or evidence of any auto-immune disease. Subjects with vitiligo,type I diabetes mellitus,residual hypothyroidism due to autoimmune condition only requiring hormone replacement,psoriasis not requiring systemic treatment,or conditions not expected to recur in the absence of an external trigger are permitted to enroll. E-11. Subjects with another pathology requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids,and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. E-12. Known hypersensitivity to any component of the products (study drug or ingredients) E-13. Concurrent administration of any other antitumor therapy E-14. Clinically significant,uncontrolled heart disease (including history of any cardiac arrhythmias,e.g.,ventricular,supraventricular,nodal arrhythmias,or conduction abnormality within 12 months of screening). E-15. Vaccinated with live attenuated vaccines within 4 weeks of the first dose of the study drug E-16. Pregnant or breast-feeding female patient E-17. Patient under guardianship or deprived of his liberty by a judicial or administrative decision,patients under safeguards of justice or incapable of giving its consent,patients undergoing psychiatric care under duress E-18. Participation in another clinical study with an investigational product during the study
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by INSTITUT GUSTAVE ROUSSY (France) and funded by THE CHILDREN'S CANCER AND LEUKAEMIA GROUP .
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for Trial ID: CPMS 57095
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